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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K100035
Device Name MODEL VISULAS 532S LASER WITH THE VITE OPTION
Applicant
Carl Zeiss Meditec, AG
5160 Hacienda Dr.
Dublin,  CA  94568
Applicant Contact JUDITH A BRIMACOMBE
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/06/2010
Decision Date 03/17/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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